Kornimate/medical-research-clean huggingface dataset:
salivary iga and cytokines response to dietary supplementation of lactobacillus reuteri

Conditions: Dental Caries; Periodontitis

Summary: to evaluate the effect of daily ingestion of the probiotic lactobacillus reuteri on the levels of secretory iga and the cytokines il1-beta, il-6, il-8 and il-10 in saliva of healthy young adults.

study design: a randomized, double-blind, cross-over design separated by three weeks run-in and wash-out periods. each intervention period is three weeks and the participants are allocated to the test and placebo regimes in a randomized order. material: 41 healthy adults are enrolled after informed consent from the school of dentistry, university of copenhagen. methods: samples of resting, unstimulated whole saliva (uws) and stimulated whole saliva (sws) are collected five times during the study period. the samples are immediately frozen in 0.5 ml aliquots. intervention: the subjects are instructed to ingest two tablets containing lactobacillus reuteri or placebo, twice daily for 3 weeks. no probiotic food or health products are allowed during the intervention period. all normal oral hygiene routines should be maintained during the entire study. the compliance is checked through interviews. any perceived side effects are reported without delay to the research staff. endpoints: the concentration of total protein and secretory iga in saliva are determined with the enzyme-linked immune-sorbent assay (elisa). the levels of the cytokines il1-beta, il-6, il-8 and il-10 is determined by luminex-technology. scientific importance: the study may provide evidence that probiotic supplements can influence the innate defense system in the whole saliva which may open up for novel strategies to combat oral diseases.

Eligibility criteria:
inclusion criteria: * healthy individuals with no chronic compromising illnesses * no medication intake for serious chronic diseases * no regular intake of probiotic products up till one month before inclusion exclusion criteria: * recent antibiotic therapy (within the last six months) * pregnant or lactating women * active infection that needs treatment with antibiotics

Keywords: probiotics oral health innate immunity
treatment patterns and treatment outcomes for acromegaly

Conditions: Acromegaly

Summary: this is a human, prospective and retrospective, single-center study of patients who have undergone treatment for acromegaly in new york city since 1981. the project will characterize, among other factors, the treatment methods received by patients, who administered the treatments and the success of this therapy in terms of biochemical control.

the first phase of this study will be to contact all subjects in the cohort by a mailing introducing them to the study. this will be followed by a phone call and administration of a questionnaire by phone or by mail. the questionnaire will collect current information on acromegaly treatment, morbidities other relevant history. subjects will provide verbal consent to participate in this questionnaire part of the study and review of their medical records by the principal investigator (pi) and study staff. in the second phase of the study, subjects will be invited to come for a visit that will be conducted by the pi and study staff at the pituitary center of columbia university irving medical center. at this visit written informed consent will be obtained. the investigators will review the subjects' medical history that is obtained from the subject and review any records and laboratory test results provided by the subject and conduct clinical and laboratory assessments. although all subjects participating in phase 1 will be invited to participate, it is estimated that 120 of the subjects invited will come for the one visit over the 2-year time frame of this study. in the third phase of the study a chart review for collection will be conducted and all data will be compiled. all subjects agreeing to participate, both in person and by mail, a chart review of all relevant patient data including demographic, clinical, biochemical, surgical and follow up information. data from questionnaires and record reviews will be compiled for analysis.

Eligibility criteria:
inclusion criteria: * adult males and females. * ages 18 and over. * presenting to the pi or one of the sub-investigators for evaluation of acromegaly. * must be an acromegaly subject that have undergone pituitary surgery with dr. bruce or dr. post or present it to principal investigator dr. pamela freda at the neuroendocrine unit at columbia university medical center for evaluation of acromegaly. exclusion criteria: * subjects who are unwilling to comply with the procedures outlined in the study. * subjects who do not have the ability to fully comprehend the nature of the study, to follow instructions, and/or cooperate with study procedures. * not being treated for acromegaly either by dr. bruce, dr. post or dr. freda. * are unwilling to provide informed consent to participate in the study.

Keywords: acromegaly
holmium versus bipolar en bloc transurethral resection of urothelium tumor of the urinary bladder

Conditions: Urinary Bladder Neoplasm

Summary: en bloc resection of bladder tumors (erbt) may improve staging quality and perioperative morbidity and influence tumour recurrence

modern laser technology has led to new alternatives to conventional turbt (cturbt). the advocates of erbt have three goals: to improve resection quality, lower perioperative complication rates, and decrease recurrence rates at resection sites. the present study is the first to compare the results of laser and electric en bloc resection of bladder cancer with respect to the aforementioned goals. the investigators aim to compare the clinical outcome in the form of safety and efficacy between holmium and bipolar transurethral en bloc resection of urinary bladder tumors.

Eligibility criteria:
inclusion criteria: * adult patients of both sexes presented with urinary bladder tumor aiming for complete resection as diagnosed by ultrasound with or without ct prior histopathological assessment. exclusion criteria: * patients with signs of extravesical tumor extension where complete resection will not beneficial or unable to proceed to complete resection due to huge tumor burden either huge single tumor more than 5 cm or multiple tumors that are not candidate for complete resection.

Keywords: urinary bladder tumors en bloc resection holmium laser bipolar turbt
estimation of the burden of rotavirus gastroenteritis (rv ge) in children less than 5 years in greece

Conditions: Rotavirus Gastroenteritis

Summary: the purpose of this study is to measure the disease burden from rv ge among children less than 5 years of age using hospital surveillance data. in addition, data collected will determine the seasonal distribution, disease severity, age distribution of rv ge. from an economic standpoint, the cost and impact of rv will also be assessed.


Eligibility criteria:
inclusion criteria: * a male or female child \< 5 years of age at the time of the visit (a child becomes ineligible on the day of her/his 5th birthday). * child is brought to the emergency room for acute ge during the study period or develop acute ge at least 48 hours after hospitalisation. * written informed consent obtained from the parent/guardian of the subject. * children with rv positive stool sample will be enrolled in the study. exclusion criteria: • not applicable.

Keywords: gastroenteritis burden rotavirus < 5 years greece children
per-oral endoscopy pyloromyotomy (g-poem) in the treatment of refractory diabetic gastroparesis : prospective evaluation of efficacy

Conditions: Gastroparesis

Summary: the objective of the study is to document the clinical efficacy and complications of endoscopic pyloromyotomy in patients with refractory gastroparesis (diabetic, post-operative and idiopathic), compared to botulinic toxin injection intra-pyloric the results of which are close to the placebo.

gastroparesis is a functional disease affecting 4% of the population, which is consecutive to diabetes in 30% of cases and considerably alters the patients' quality of life. the diagnosis is based on gastric fullness symptoms, endoscopy and gastric emptying scintigraphy. the therapeutic alternatives including drug therapies (metoclopramide, erythrocin), surgery (electric gastric stimulation) or endoscopy (botulinic toxin), are insufficiently effective. two surgical series suggested an interesting efficacy of laparoscopic pyloroplasty, which remains invasive for a motility disorder. more recently, an us team performed the first case of g-poem with an excellent outcome and no adverse event. this promising result was confirmed by a brazilian case, a short retrospective series (7 patients) and the first european case performed and published by our team that has performed 5 cases since. based on experience, it is proposed a prospective monocentric study to evaluate the efficacy of the g-poem technique on refractory gastroparesis. this study will include 40 patients on a period of three years, whom suffer from refractory gastroparesis, confirmed by clinical evaluation (gcsi and analogic visual scale), upper gi endoscopy and gastric emptying scintigraphy at the inclusion.

Eligibility criteria:
inclusion criteria: * older than 18 years. * presenting a clinical refractory gastroparesis for\> 1 year, that is to say whose functional nonspecific symptoms persisting despite medical therapy (prokinetic) optimal. * having a calculation before inclusion gcsi score (gastroparesis cardinal symptom index) and a scan of the pathological gastric emptying finding gastroparesis older than 3 months. * no history of gastric surgery (partial gastrectomy sleeve gastrectomy, ...) or esophageal surgery * not having endoscopic gastric lesions (ulcers antro-pyloric cancer). * having no indication against anesthetic. * having consented to participate in the study. * affiliated with a social security scheme (beneficiary or assignee). exclusion criteria: * minors. * pregnant or breastfeeding * having an anesthetic against indication. * scan the normal gastric emptying * under curative dose anticoagulants whose suspension is inappropriate. * under dual anti-platelet aggregation whose suspension is inappropriate. * being unable to give informed consent
the membrane adsorbing oxiris filter in septic patients with aki

Conditions: Sepsis; Acute Renal Failure

Summary: patients with sepsis / septic shock and aki are submitted to continuous renal replacement therapy with the oxiris filter . the pro- inflammatory mediators , the endotoxin , interleukin 10 , the main cardiorespiratory indices and renal parameters are evaluated at the entry of the study and at the end of the treatment.

patients with a diagnosis of sepsis or septic shock gram + , gram - and acute renal failure all patients are submitted to continuous renal replacement therapy with the treated heparin-coated membrane (oxiris;baxter ); * citrate anticoagulation or heparin with thromboelasthograpy monitoring . * hemodynamic monitoring with dynamic parameters ( cardiac index ,stroke volume variation , pulse pressure variation ) and echocardiography * indirect calorimetry ( before continuous renal replacement therapy and after 1 hour stopping continuous renal replacement therapy ) * laboratory: white blood cell, creatinine, procalcitonin, interleukin -6, interleukin -10, endotoxin , lactate, diuresis, tromboelastography (post filter and arterial sample ) and dosage of plasminogen activator inhibitor -1 at the same sites.

Eligibility criteria:
inclusion criteria:- age \ * diagnosis of sepsis or septic shock (sepsis iii) * mechanical ventilation or non invasive ventilation with pao2 /fio2 \< 200. * renal failure ( aki ≥ 1) * endotoxin ( eaa ) : eaa ≥ 0.6 -0.9 \> or il6 \> 150 pg/ml exclusion criteria: * pregnancy; * age \ * chronic renal failure or previous crrt * immunological disease or immunosuppressive drugs or eaa \< 0.6 with il 6 in the normal range. * cgs \< 8 due to hemorrhagic or ischemic event. * ecmo v-v or a-v or ecco2 removal. * no resolution of the surgical source of infection * terminal condition * any contraindication to heparin and other anticoagulant. * other pathological conditions in which the oxiris filter is not indicated and other therapeutic options are required. (eg . hepatic failure , cardiac failure )

Keywords: sepsis acute renal failure extra corporeal therapy
comparison of the efficacy of phototherapy using blue led's with wavelength 478 vs. 459 nm.

Conditions: Neonatal Jaundice

Summary: treatment of neonatal jaundice is phototherapy with blue light at wavelength about 460 nm and irradiance \> 30 uw/cm2/nm. though, recent in vitro models have suggested that a wavelength of 478 nm should be optimal in reducing total serum bilirubin. the aim of this study is therefore to compare the efficiency of phototherapy with light emitting diodes (led's) of 478 vs. 459 nm., respectively.

this is a prospective randomised study of the efficacy of phototherapy. inclusion criteria are gestational age \> 33 weeks and birth weight \> 1800 grams, uncomplicated neonatal jaundice. the infants should be treated with phototherapy in a cradle for 24 hours, which is routine standard of care. exclusion criteria is haemolytic disease. total serum bilirubin (tsb) is measured before and after 24 hours of phototherapy. the infants are enrolled and randomised consecutively by the neonatologist using sealed and opaque envelopes. power calculation based on expected difference in decrease of tsb of 6% between the two groups and a significance level of 0.05, showed that 48 infants should be enrolled in each group.

Eligibility criteria:
inclusion criteria: * indication for phototherapy with single light * gestational age \> 33 weeks * birth weight \> 1800 grams * should be treatable in a cradle exclusion criteria: * haemolytic disease * indication for double/triple phototherapy or exchange transfusion
the relationship between physical activity levels and anxiety, depression, stress of disabled athletes

Conditions: Paralympic Athletes

Summary: it is aimed to investigate the relationship between anxiety, depression, stress and physical activities of disabled athletes prepared for the paralympic games to be held in tokyo in 2021, 3 times in total at 2-3 months intervals, and to determine the change over time


Eligibility criteria:
inclusion criteria: * being a physically disabled athlete * preparation for the paralympic games * volunteering to participate in the study exclusion criteria: * serious psychiatric illness * regular use of sedatives or neuropsychiatric drugs * presence of active alcohol or drug addiction * presence of a systemic or neurological problem that develops independent of disability pathology.
rp5063 in subjects with schizophrenia or schizoaffective disorder

Conditions: Acute Schizophrenia; Schizoaffective Disorder

Summary: the objective of this study is to evaluate the efficacy and safety of rp5063 relative to placebo for the treatment of schizophrenia or schizoaffective disorder.


Eligibility criteria:
inclusion criteria: * patients providing informed consent prior to any study specific procedures * patients meeting diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), or schizoaffective disorder * patients with normal physical examination, laboratory, vital signs,and electrocardiogram (ecg) exclusion criteria: * patients with other primary psychiatric disorders as delirium, or bipolar i or ii disorder
risa extension study - long term safety

Conditions: Asthma

Summary: the primary purpose of this study is to gather additional safety data for the subjects treated with the alair system (hereinafter, "alair-treated subjects") who previously completed the one-year study entitled: "multicenter randomized clinical trial of bronchial thermoplasty with the alair system for the treatment of severe asthma" (protocol #0903-27) sponsored by asthmatx, inc. subjects who elect to participate in this safety study will be followed for an additional four (4) year period beyond the predecessor study's one-year endpoint (clinicaltrials.gov number nct00214539).

this will be a multicenter study conducted only at the clinical sites that participated in the predecessor study (nct00214539). enrollment will be limited to only those subjects who were treated with the alair system in the predecessor study. written, informed consent will be obtained from all subjects prior to performing any study procedures. the present study will extend the follow-up evaluation of alair-treated subjects from the predecessor study to 5 years post-treatment with the alair system. these evaluations will consist of four study visits corresponding to the two-year, three-year, four-year and five-year time points following completion of alair treatments in the predecessor study. for consistency with the predecessor study, ideally the subject's drug therapy should continue to be consistent with gina (global initiative for asthma) guidelines for the severity of the subject's asthma. any changes in maintenance levels of asthma medications will be documented. the goal of this follow-on study is to enroll all alair-treated subjects who completed the predecessor study. inclusion of subjects from the treatment arm will allow for better assessment of the long-term safety of the alair procedure.

Eligibility criteria:
inclusion criteria: * subject who participated in the predecessor study entitled "multicenter randomized clinical trial of bronchial thermoplasty with the alair™ system for the treatment of severe asthma" (protocol # 0903-27). * subject was treated with the alair system ("alair group") in the predecessor study. * subject who is able to read, understand, and provide written informed consent. * subject who is able to comply with the study protocol, including requirements for taking and abstaining from medications, and complete all study required visits. exclusion criteria: * subject participating in another clinical trial involving respiratory intervention that could affect the outcome measures of this study, either within 6 weeks of study enrollment, or during the study period. * subject with a newly diagnosed (since exiting from the predecessor study) psychiatric disorder which in the judgment of the investigator could interfere with provision of informed consent, completion of tests, therapy, or follow-up.

Keywords: refractory asthma bronchial thermoplasty alair system risa (research in severe asthma)
exercise versus corticosteroid randomized clinical trial for plantar fasciitis

Conditions: Fasciitis, Plantar

Summary: chronic plantar fasciopathy is a painful condition common in the workplace, particularly for those workers required to stand for long periods of time, and is typically associated with point tenderness at heel and arch of the foot. this clinical trial will investigate the effectiveness of an innovative multi-element exercise program versus the standard of care for plantar fasciopathy. the observation period will be 12-weeks. outcomes are determined through questionnaire and ultrasound imaging. workers with long-standing plantar fasciopathy who must stand for prolonged periods of time (i.e. \> 6 hours) during their workday will be invited to participate in this study. after ensuring eligibility, each subject will be randomly assigned to either the intervention group who will receive a multi-element exercise program, or the control group who will receive a cortisone injection followed by a stretching program for their calf-muscles (standard of care). the treatment length for both groups will be 12-weeks.


Eligibility criteria:
inclusion criteria: * adult workers (men and women) between the ages of 19 and 60 * workers required to stand for 6 hours or more in their respective workplaces * diagnosed with plantar fasciopathy (plantar fasciitis). all diagnoses will be made by a physiotherapist based on the presentation of palpable pain at or around the plantar medial heel, in addition to pain during weight-bearing activities and the presence of morning pain. * only individuals with pain for longer than 12 months will be included. exclusion criteria: * a history of surgery to their plantar fascia * osteoarthritis or other degenerative musculoskeletal disorders affecting the lower extremity * individuals who have received corticosteroid injections into their affected plantar fascia at any time in the past will be excluded.

Keywords: chronic plantar fasciitis workplace injury foot and ankle disability index ultrasound measure of disease severity
sequential tranylcypromine (tc), tc + dextroamphetamine and tc + triiodothyronine for refractory depression

Conditions: Major Depression

Summary: this pilot study will assess the efficacy of several sequential pharmacological treatments for patients with refractory depression.

this pilot study will recruit 40 patients with major depression and a history of at least two failed prior adequate somatic treatments. in addition to usual physical work-up, all patients will have extensive thyroid testing, and then will receive standard dose tranylcypromine (i.e., max. 60 mg/d). non-remitters will have dose increased to max. 120 mg/d if tolerated. non-remitters to high dose tranylcypromine will then have dextroamphetamine added with frequent blood pressure monitoring to max. 40 mg/d. non-remitters will have triiodothyronine added to the tranylcypromine.

Eligibility criteria:
inclusion criteria: * ages between 18-65 * major depression * at least two prior ineffective antidepressant trials (at least 2 different mechanisms) or 1 inadequate ect trial (at least 8 bilateral treatments) * physically healthy exclusion criteria: * known tranylcypromine allergy * unable to follow tyramine-free diet * known allergy, intolerance or prior addiction to any stimulant would preclude patient's inclusion in the dextroamphetamine portion of the protocol * current substance use disorder including alcohol)(past six months); ever dependent on stimulants would preclude dextroamphetamine portion of the protocol * unable or unwilling to discontinue antidepressants including otc antidepressants such as st. john's wort * history of psychosis, such as schizophrenia or psychotic depression; history of bipolar mania will be allowed if on adequate mood stabilizer * suicidal ideation/activity that makes outpatient treatment unsafe, unless protocol can be conducted as inpatient * current systolic bp \> 149 or diastolic bp \> 89 mm hg (two readings); adequately treated hypertension is acceptable * evidence of hypo- or hyperthyroidism * pregnancy, lactation, refusal to use adequate birth control

Keywords: major depression refractory depression tranylcypromine dextroamphetamine triiodothyronine